Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Milan, Italie
- Fondazione IRCCS Istituto Nazionale dei Tumori
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients undergoing major abdominal surgery
- age between 18 and 70 years
- ASA class 1 or 2
- patients scheduled for blended anesthesia (epidural + general anesthesia)
- patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).
Exclusion Criteria:
- known or suspected respiratory, cardiovascular or neuromuscular disease
- renal or hepatic failure
- known or suspected allergies to drugs used in the study
- risk for malignant hyperthermia
- pregnancy
- diagnosed depressive disorder
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Sugammadex
|
sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v.
(0,1 ml/kg)
Autres noms:
|
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Comparateur placebo: Sodium chloride solution
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Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
Délai: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
Délai: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
Délai: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Forced Vital Capacity (FVC) changes after placebo or sugammadex
Délai: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
Délai: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Hemogasanalysis parameters changes after placebo or sugammadex
Délai: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Swallow ability changes after placebo or sugammadex
Délai: 10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Federico Piccioni, MD, Fondazione IRCCS Istituto Nazionale dei tumori - Milan
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- INT-66/11
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